Tissue removing

ABSTRACT

Devices, systems, and methods of the present disclosure are directed to efficient and accurate removal of tissue from a three-dimensional anatomic structure, such as a breast, of a patient. For example, a cup can be positioned on the patient&#39;s breast to conform the breast (e.g. via suction) to a known three-dimensional contour, and a cutting tip can be moved along the three-dimensional contour at one or more predetermined distances from at least one surface of the cup. The cutting tip can remove tissue along the three-dimensional contour to form a skin envelope. As compared to a manual process performed by a surgeon, formation of the envelope through controlled movement of the cutting tip along the three-dimensional contour can improve control over dimensions of the envelope, thus, facilitating achievement of consistent outcomes by reducing the likelihood of complications associated with an envelope that is too thick, too thin, or uneven.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. ProvisionalPatent Application No. 62/651,452, filed Apr. 2, 2018, the entirecontents of which are hereby incorporated herein by reference.

BACKGROUND

Breast cancer treatment often includes surgical intervention. Forexample, a lumpectomy can be performed to remove abnormal tissue, and aportion of surrounding tissue, from the breast while conserving as muchbreast tissue as possible. As another example, a mastectomy can beperformed to remove all breast tissue from a breast of the patient,leaving a skin envelope. In many cases, following the mastectomy, breastimplants can be placed in the skin envelope as part of a reconstructivesurgery. Historically, a mastectomy can be part of the treatment ofbreast disease in instances in which a lumpectomy is not feasiblealthough that trend is changing and mastectomy is increasingly becominga first line of surgical treatment.

Although it is a more invasive option, a mastectomy is sometimes chosenas an alternative to the less invasive option of a lumpectomy. Forexample, some patients with early-stage disease treatable with alumpectomy may, nevertheless, opt for a mastectomy for a variety ofreasons, such as to avoid radiation treatment or to have more aestheticreconstruction. As another example, some patients with no cancerdiagnosis but with a genetic predisposition to breast cancer, may optfor a prophylactic mastectomy. Thus, in recent years, the number ofmastectomies has increased, even as the diagnosis of breast cancer hasbeen stable.

While mastectomies can be an effective part of breast cancer treatmentor prevention, the surgery is performed manually and the anatomicgeometry is three-dimensional and highly variable from patient topatient. Thus, mastectomies can be time consuming and subject tovariable outcomes. More specifically, a mastectomy can take betweenabout 60-120 minutes per breast to perform, depending on the size,shape, tissue quality of the breast, and the skill set of the mastectomysurgeon. Because of the complex nature of this manual procedure, theconsistency and quality of a skin envelope formed through removal of thebreast tissue can deviate from an ideal skin envelope. If the skinenvelope is too thick, breast tissue may be left behind, increasing therisk of recurrence of the cancer. Conversely, if the skin is too thin,the skin envelope may suffer ischemia, resulting in wound healingproblems, and in the case of reconstruction, potential loss of implants.Thus, there remains a need for reducing the time associated withperforming a mastectomy while also reducing deviations from an idealskin envelope.

SUMMARY

Devices, systems, and methods of the present disclosure are directed toefficient and accurate removal of tissue from a three-dimensionalanatomic structure, such as a breast, of a patient. For example, a cupcan be positioned on the patient's breast to conform the breast (e.g.,via suction) to a known three-dimensional contour, and a cutting tip canbe moved along the three-dimensional contour at one or morepredetermined distances from at least one surface of the cup. Thecutting tip can remove tissue along the three-dimensional contour toform a skin envelope. As compared to a manual process performed by asurgeon, formation of the envelope through controlled movement of thecutting tip along the three-dimensional contour can improve control overdimensions of the envelope, thus facilitating achievement of consistentoutcomes by reducing the likelihood of complications associated with anenvelope that is too thick, too thin, or uneven.

According to one aspect, a system for removal of tissue from a patientcan include a cup and a cutting head. The cup can have at least onesurface, the at least one surface defining a volume and a first opening,and the volume positionable about a breast of a patient with the atleast one surface of the cup facing a skin surface of the breast and thefirst opening circumscribing the breast of the patient. The cutting headcan be secured (e.g., releasably secured) to the cup, and the cuttinghead can include an actuator and a cutting tip. The actuator can becoupled to the cutting tip, and the actuator can be controllable to movethe cutting tip, within the volume, along a three-dimensional contour atone or more predetermined distances from the at least one surfacedefining the volume and the first opening.

In certain implementations, the actuator can be controllable to move thecutting tip along the three-dimensional contour parallel to the at leastone surface of the cup. Further, or instead, one or more of the volumeand the first opening can be symmetric about at least one planeperpendicular to the first opening.

In certain implementations, a cross-section of the volume in at leastone plane parallel to the first opening is curvilinear. For example, thecross-section of the volume in the at least one plane parallel to thefirst opening can be substantially elliptical. Further, or instead, thevolume defined by the at least one surface of the cup can befrustoconical. Additionally, or alternatively, at least one portion ofthe volume can be concave. That is, for example, at least one portion ofthe volume can have a two-dimensional curvilinear profile (e.g., an arc)in one or more planes perpendicular to the first opening.

In some implementations, the at least one surface of the cup can furtherdefine a second opening, the volume extending from the first opening tothe second opening, and the cutting head extending through the secondopening. The volume can be, for example, symmetric about at least oneplane intersecting the first opening and the second opening. Further, orinstead, the first opening can have a first area and the second openingcan have a second area, and the second area can be less than the firstarea. In certain instances, a gasket can be disposed along the firstopening. The gasket can be pliable (e.g., formed of one or more ofsilicone or rubber) The gasket can be, for example, releasablypositionable along the first opening.

In certain implementations, the actuator can include a pivot arm and anextension arm coupled to the pivot arm. The pivot arm and the extensionarm can be movable in coordination with one another to move the cuttingtip along the three-dimensional contour. In certain instances, the pivotarm can be rotatable about a first axis defined by the pivot arm, theextension arm can be axially movable along a second axis defined by theextension arm and intersecting the first axis, and the pivot arm and theextension arm can be movable relative to one another to change anincluded angle between the first axis and the second axis.

In some implementations, the cutting tip can include a resistanceelement. For example, the cutting tip can define a track, and theresistance element can be movable back and forth along the track. Thecutting tip can include, for example, one or more sensors adjacent tothe resistance element. The one or more sensors can include tissuesensors. Returning to the example of the resistance element movablealone a track, at least one of the tissue sensors can be disposed oneach side of the track along which the resistance element is movable.Further, or instead, the one or more sensors can include a pressuresensor arranged to detect contact pressure between the cutting tip andtissue. Additionally, or alternatively, the one or more sensors caninclude a capacitance sensor. Still further or instead, the one or moresensors can include a blood sensor, a temperature sensor, or both. Insome instances, the cutting tip can include a position sensor configuredto sense a distance from the cutting tip to the at least one surface ofthe cup defining the volume and the first opening. In certain instances,the cutting tip can define one or more suction channels adjacent to theresistance element.

In some implementations, at least one of the cutting head and the cupcan define a suction lumen in fluid communication with the volumedefined by the at least one surface of the cup. In some instances, thesystem can further include a suction source in fluid communication, viathe suction lumen, with the volume defined by the at least one surfaceof the cup, wherein, with the cup positioned about the breast of thepatient, the suction source is actuatable to form vacuum pressure in thevolume to draw the skin surface of the breast toward the at least onesurface of the cup.

In certain implementations, the at least one surface of the cup can berigid upon exposure to vacuum pressure.

In some implementations, the system can further include an adhesivedisposed along at least a portion of the at least one surface of thecup.

In certain implementations, at least a portion of the at least onesurface of the cup can be textured to resist movement of the at leastone surface of the cup relative to the skin surface of the patient.

In some implementations, the system can further include a controller inelectrical communication with the actuator and the cutting tip, thecontroller including one or more processors and a non-transitory,computer readable storage medium having stored thereon computerexecutable instructions for causing the one or more processors to sendone or more control signals to the actuator, the one or more controlsignals associated with positioning the cutting tip along thethree-dimensional contour at the one or more predetermined distancesfrom the at least one surface defining the volume and the first opening,and send an activation signal to the cutting tip to dissect tissue alongthe three-dimensional contour. Further or instead, the non-transitory,computer readable storage medium can have further stored thereoncomputer executable instructions for causing the one or more processorsto receive an electrical signal indicative of size of the cup and, basedon a size of the cup, determine the three-dimensional contour. Incertain instances, the cup can include, for example, a transmitterincluding size information related to the cup, the cutting head includesa receiver configured to communicate with the transmitter to receive asignal indicative of the size information related to the cup. Further,or instead, the transmitter can include a passive electrical circuit,the passive electrical circuit having one or more electricalcharacteristics indicative of the size information related to the cup.Still further or instead, the transmitter can be configured for wirelesscommunication with the receiver. Additionally, or alternatively, thetransmitter can be connectable in wired electrical communication withthe receiver. In certain instances, the cutting tip can define a tipaxis and the one or more control signals can control an angle of the tipaxis tangent to the three-dimensional contour. Still further or instead,the non-transitory, computer readable storage medium can have furtherstored thereon computer executable instructions for causing the one ormore processors to receive at least one user input corresponding to theone or more predetermined distances from the at least one surfacedefining the volume and the first opening.

According to another aspect, a device can include a cup, a coupling, anda transmitter. The cup can define a first opening and a second opening,the cup having at least one surface extending from the first opening tothe second opening, the at least one surface defining a volumepositionable about a breast of a patient with the at least one surfaceof the cup facing a skin surface of the breast and the first openingcircumscribing the breast of the patient. The coupling can be disposedon the cup and adjacent to the second opening, the coupling releasablysecurable in sealed engagement with a cutting head extending through thesecond opening. The transmitter can be carried on the cup, thetransmitter including information related to the cup.

In some implementations, a cross-section of the volume in at least oneplane parallel to the first opening can be curvilinear. For example, thecross-section of the volume in the at least one plane parallel to thefirst opening is substantially elliptical. In some instances, the volumedefined by the at least one surface of the cup can be frustoconical.Further, or instead, at least one portion of the volume can be concave.As an example, at least a portion of the volume has a two-dimensionalcurvilinear profile (e.g., an arc) in one or more planes perpendicularto the first opening.

In certain implementations, a cross-section of the volume can besymmetric about at least one plane intersecting the first opening andthe second opening. For example, at least one plane bisects the firstopening and the second opening.

In some implementations, the at least one surface of the cup can berigid upon exposure to vacuum pressure.

In certain implementations, the device can further include a gasket(e.g., a pliable gasket) disposed about the second opening. The gasketcan be releasably positionable along the second opening. Additionally,or alternatively, the gasket can be formed of silicone, rubber, or acombination thereof.

In some implementations, the device can further include an adhesivedisposed on at least a portion of the at least one surface along thevolume.

In certain implementations, the transmitter can be activatable totransmit the information related to the cup to a remote receiver. Thetransmitter can include, for example, a passive RFID tag.

In some implementations, the transmitter can include a portion of anelectrical circuit, the portion of the electric circuit having one ormore electrical properties indicative of the information related to thecup, the transmitter connectable in electrical communication with areceiver carried on the cutting head to complete the electrical circuit.The portion of the electric circuit can have, for example, apredetermined impedance associated with size information of the cup.Further, or instead, the transmitter can include one or more conductivepins, the one or more conductive pins associated with size informationof the cup, and the one or more conductive pins connectable withrespective one or more receptacles defined by the receiver carried onthe cutting head to complete the electrical circuit.

In certain implementations, the transmitter can include a memory, thememory having stored thereon information related to use history of thecup.

In some implementations, the transmitter can be connectable in opticalcommunication with a receiver carried on the cutting head. For example,the transmitter can include a QR code, a bar code, or both associatedwith size of the cup. Additionally, or alternatively, the transmittercan be activatable to transmit light of a predetermined wavelengthassociated with size of the cup.

According to yet another aspect, a method of controllingthree-dimensional dissection of tissue can include receiving anidentification signal indicative of size of a cup, the cup having atleast one surface, the at least one surface defining a volume and afirst opening, based on the identification signal, determining athree-dimensional contour within the volume, the three-dimensionalcontour spaced apart from the at least one surface at one or morepredetermined distances, sending one or more control signals to anactuator coupled to a cutting tip, the actuator coupled to the cup andextending into the volume defined by the at least one surface of thecup, the one or more control signals associated with positioning thecutting tip along the three-dimensional contour, and sending anactivation signal to the cutting tip to dissect tissue along thethree-dimensional contour to form at least a portion of a skin envelope.

In certain implementations, receiving the identification signal caninclude sending an interrogation signal to the cup. The interrogationsignal can be, for example, an electrical signal. Further, or instead,the interrogation signal can be an optical signal. Still further, orinstead, the interrogation signal can be an RF signal.

In some implementations, the identification signal can be furtherindicative of use history of the cup, and sending the one or morecontrol signals to the actuator can be based on whether the use historyof the cup is below a predetermined threshold.

In certain implementations, the three-dimensional contour can beparallel to and spaced apart from the at least one surface of the cup.

In some implementations, determining the three-dimensional contourwithin the volume can include receiving the one or more predetermineddistances from an input device.

In certain implementations, determining the three-dimensional contourwithin the volume can include detecting one or more electricalproperties of the identification signal, the one or more electricalproperties associated with a size of the cup. Further, or instead, theone or more electrical properties of the identification signal caninclude detecting a predetermined impedance associated with the size ofthe cup. Additionally, or alternatively, the one or more electricalproperties of the identification signal can include detecting a pinconfiguration of the cup, the pin configuration associated with the sizeof the cup.

In some implementations, determining the three-dimensional contourwithin the volume can include detecting one or more optical propertiesof the identification signal, the one or more optical propertiesassociated with the size of the cup. For example, the one or moreoptical properties can include a predetermined wavelength of lightassociated with size of the cup.

In certain implementations, the actuator can have a plurality of degreesof freedom, and sending the one or more control signals to the actuatorcan include sending a respective control signal associated with eachdegree of freedom of the actuator.

In some implementations, the cutting tip can define a tip axis, and theone or more control signals can position the tip axis tangent to thethree-dimensional contour.

In certain implementations, the method can further include sending analert signal to a user interface, the alert signal based on proximity ofthe cutting tip to a predetermined region of the volume.

According to still another aspect, a computer program product is encodedon one or more non-transitory computer storage media, the computerprogram product comprising instructions that, when executed by one ormore computing devices, cause the one or more computing devices toperform operations including receiving an identification signalindicative of size of a cup, the cup having at least one surface, the atleast one surface defining a volume and a first opening, based on theidentification signal, determining a three-dimensional contour withinthe volume, the three-dimensional contour spaced apart from the at leastone surface at one or more predetermined distances, sending one or morecontrol signals to an actuator coupled to a cutting tip, the actuatorcoupled to the cup and extending into the volume defined by the at leastone surface of the cup, the one or more control signals associated withpositioning the cutting tip along the three-dimensional contour, andsending an activation signal to the cutting tip to dissect tissue alongthe three-dimensional contour to form at least a portion of a skinenvelope.

According to yet another aspect, a computer program product is encodedon one or more non-transitory computer storage media, the computerprogram product comprising instructions that, when executed by one ormore computing devices, cause the one or more computing devices toperform operations including receiving a signal indicative of a vacuumpressure in a volume at least partially defined by at least one surfaceof a cup, positioning a cutting tip along a three-dimensional contourwithin the volume, the three-dimensional contour spaced apart from theat least one surface of the cup at one or more predetermined distances,and, based on the received signal, selectively activating the cuttingtip to dissect tissue of a patient along the three-dimensional contour.

In certain implementations, the signal indicative of the vacuum pressurein the volume can be received from a pressure sensor in fluidcommunication with the volume.

In some implementations, the signal indicative of the vacuum pressure inthe volume can be received over a predetermined period of time. Forexample, selectively activating the cutting tip to dissect tissue of thepatient along the three-dimensional contour can be at least partiallybased on a fluctuation of the received signal over the predeterminedperiod of time.

In certain implementations, positioning the cutting tip along thethree-dimensional contour within the volume can include sending one ormore control signals to an actuator mechanically coupled to the cup andto the cutting tip. The actuator can have a plurality of degrees offreedom, and sending the one or more control signals to the actuator caninclude sending a respective control signal associated with each degreeof freedom of the actuator. Further, or instead, the cutting tip candefine a tip axis, and the one or more control signals can position thetip axis tangent to the three-dimensional contour.

In some implementations, the three-dimensional contour can be at least aportion of an ellipsoid.

In some implementations, selectively activating the cutting tip caninclude delivering energy to the cutting tip based on whether thereceived signal corresponds to a condition at or below a predeterminedvacuum pressure in the volume.

In certain implementations, the computer program product can furtherinclude instructions that, when executed by one or more computingdevices, cause the one or more computing devices to perform operationsfurther including repeating the steps of receiving the signal,positioning the cutting tip along the three-dimensional contour withinthe volume, and selectively activating the cutting tip to dissect tissueto form a skin envelope.

According to still another aspect, a method can include receiving asignal indicative of a vacuum pressure in a volume at least partiallydefined by at least one surface of a cup disposed about a breast of apatient with the breast of the patient extending into the volume,positioning a cutting tip along a three-dimensional contour within thevolume, the three-dimensional contour spaced apart from the at least onesurface of the cup at one or more predetermined distances, and, based onthe received signal, selectively activating the cutting tip to dissecttissue of a patient along the three-dimensional contour.

In certain implementations, the signal indicative of the vacuum pressurecan be received from a pressure sensor in fluid communication with thevolume.

In some implementations, the signal indicative of the vacuum pressure inthe volume can be received over a predetermined period of time. Forexample, selectively activating the cutting tip to dissect tissue of thepatient along the three-dimensional contour can be at least partiallybased on a fluctuation of the received signal over the predeterminedperiod of time.

In some implementations, positioning the cutting tip along thethree-dimensional contour within the volume can include sending one ormore control signals to an actuator mechanically coupled to the cup andto the cutting tip. For example, the actuator can have a plurality ofdegrees of freedom, and sending the one or more control signals to theactuator can include sending a respective control signal associated witheach degree of freedom of the actuator. Further, or instead, the cuttingtip can define a tip axis, and the one or more control signals canposition the tip axis tangent to the three-dimensional contour.

In certain implementations, selectively activating the cutting tip caninclude delivering energy to the cutting tip based on whether thereceived signal corresponds to a condition at or below a predeterminedvacuum pressure in the volume.

According to still another aspect, a method of removing breast tissuefrom a patient can include selecting a cup, the cup having one or moresurfaces, the one or more surfaces defining a volume and a firstopening, securing the cup to a cutting head including an actuator and acutting tip, the actuator controllable to move the cutting tip, makingan incision in a breast of the patient, and positioning the cup aboutthe breast of the patient with the one or more surfaces of the cupfacing a skin surface of the breast and the first opening circumscribingthe breast of the patient, wherein, with the cup positioned about thebreast of the patient, the cutting tip extends through the incision andinto the breast.

In certain implementations, selecting the cup can include providing averification input to a user interface in electrical communication withthe cutting head.

In some implementations, the cup can be selected from a plurality ofcups, the plurality of cups spanning a range of sizes, and the cup isselected based on a size of the breast.

In certain implementations, making the incision can include removing anareola complex of the breast.

In some implementations, positioning the cup about the breast of thepatient can include substantially centering the cup relative to theincision in the breast of the patient.

In certain implementations, positioning the cup about the breast of thepatient can include anchoring the skin surface of the breast in a fixedposition relative to the one or more surfaces of the cup facing the skinsurface of the breast. For example, anchoring the skin surface of thebreast in the fixed position relative to the one or more surfaces of thecup facing the skin surface of the breast can include creating vacuumpressure between the skin surface of the breast and the one or moresurfaces of the cup facing the skin surface of the breast.

In certain implementations, positioning the cup about the breast of thepatient can include placing a gasket along the first opening defined bythe one or more surfaces of the cup.

In some implementations, the method can further include operating thecutting head, wherein activating the cutting head can include deliveringenergy to the cutting tip to dissect tissue and actuating the actuatorto move the cutting tip along a three-dimensional contour at one or morepredetermined distances from the one or more surfaces defining thevolume and the first opening. As an example, activating the cutting headcan include providing the one or more predetermined distances to a userinterface in electrical communication with the cutting head. Further, orinstead, activating the cutting head can further include providingsuction adjacent to the cutting tip.

Other aspects, features, and advantages will be apparent from thedescription and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of a system for removal of breast tissue.

FIG. 2 is a side view of cross-section of a cutting head and a cup ofthe system of FIG. 1, the cross-section taken along line A-A in FIG. 1.

FIG. 3 is a bottom view of the cup of the system of FIG. 1.

FIG. 4 is a schematic representation of a three-dimensional contourwithin a volume of the cup of the system of FIG. 1.

FIG. 5 is a side view of a cross-section of the cutting head of thesystem of FIG. 1, the cross-section taken along line A-A in FIG. 1.

FIG. 6 is an end view of a cutting tip of the cutting head of the systemof FIG. 1.

FIG. 7 is a flowchart of an exemplary method of controllingthree-dimensional dissection of tissue.

FIG. 8 is a flowchart an exemplary method of vacuum-based anchoring ofthree-dimensional dissection of tissue.

FIG. 9 is a flowchart of an exemplary method of removing breast tissuefrom a patient.

FIG. 10 is a schematic representation of the system of FIG. 1 positionedon a breast of a patient as a skin envelope is formed.

FIG. 11A is a side view of a frustoconical cup.

FIG. 11B is a cross-sectional view of the frustoconical cup of FIG. 11Aalong line B-B in FIG. 11A.

FIG. 12A is a side view of a cup defining suction channels.

FIG. 12B is a cross-sectional view of the cup of FIG. 12A along line C-Cin FIG. 12A.

FIG. 13 is a cross-sectional view of a portion of an actuator of acutting head including a spring and cables.

Like reference symbols in the various drawings indicate like elements.

DESCRIPTION

Embodiments will now be described with reference to the accompanyingfigures. The foregoing may, however, be embodied in many different formsand should not be construed as limited to the illustrated embodimentsset forth herein.

All documents mentioned herein are hereby incorporated by reference intheir entirety. References to items in the singular should be understoodto include items in the plural, and vice versa, unless explicitly statedotherwise or clear from the text. Grammatical conjunctions are intendedto express any and all disjunctive and conjunctive combinations ofconjoined clauses, sentences, words, and the like, unless otherwisestated or clear from the context. Thus, the term “or” should generallybe understood to mean “and/or” and, similarly, the term “and” shouldgenerally be understood to mean “and/or.”.

Recitation of ranges of values herein are not intended to be limiting,referring instead individually to any and all values falling within therange, unless otherwise indicated herein, and each separate value withinsuch a range is incorporated into the specification as if it wereindividually recited herein. The words “about,” “approximately,” or thelike, when accompanying a numerical value, are to be construed asindicating a deviation as would be appreciated by one of ordinary skillin the art to operate satisfactorily for an intended purpose. Ranges ofvalues and/or numeric values are provided herein as examples only, anddo not constitute a limitation on the scope of the describedembodiments. The use of any and all examples, or exemplary language(“e.g.,” “such as,” or the like) provided herein, is intended merely tobetter illuminate the embodiments and does not pose a limitation on thescope of the embodiments. No language in the specification should beconstrued as indicating any unclaimed element as essential to thepractice of the embodiments.

In the following description, it is understood that terms such as“first,” “second,” and the like, are words of convenience and are not tobe construed as limiting terms.

As used herein, unless otherwise indicated or made clear from thecontext, the term “physician” should be understood to include a surgeonpreparing for and/or performing any one or more of the medicalprocedures described herein and, more broadly, should be understood toinclude any medical personnel, such as nurses, assisting a surgeon inpreparing for or performing any one or more of the medical proceduresdescribed herein. Further, as used herein, the term “patient” shall beunderstood to include any type of mammal, including a human, on which amedical procedure such as, but not limited to a mastectomy and/or tissueharvesting, can be performed.

Further, as used herein, unless otherwise indicated or made clear fromthe context, the term “skin envelope” should be understood to refer to athree-dimensional volume defined by skin of the patient remainingfollowing removal of tissue such as breast tissue. As an example, thethree-dimensional volume defined by the skin envelope may receive animplant as part of certain types of reconstruction following a proceduresuch as a mastectomy. While the three-dimensional volume defined by theskin envelope may be usefully described in terms of the ability toreceive an implant, it should be appreciated that, post-mastectomy,reconstruction using an implant is optional. That is, even in instancesin which an implant is not used to reconstruct the breast following amastectomy, a skin envelope is nevertheless formed by the removal ofbreast tissue.

Referring now to FIGS. 1-6, a system 100 for removal of tissue from apatient can include a cup 102, a cutting head 104, a controller 106, anda user interface 107. The cutting head 104 can be secured (e.g.,releasably secured) to the cup 102 via a coupling 108 and can include,for example, an actuator 109 and a cutting tip 110. The controller 106can be in one or more of electrical and mechanical communication withone or more of the cup 102, the cutting head 104, and the user interface107 to control the actuator 109 and the cutting tip 110 to remove tissuealong a three-dimensional contour 111 defined relative to the cup 102.In general, the system 100 can account for variations in breast size andshape during formation of a skin envelope as part of a mastectomy. Morespecifically, by accounting for three-dimensional complexity of thebreast, the system 100 can advantageously reduce the time and likelihoodof dimensional inaccuracy of skin envelope formation (e.g., thicknessthat is too thin or too thick in certain areas), as compared to skinenvelopes formed using manual techniques. For the sake of clarity ofexplanation, the system 100 is generally described herein with respectto the removal of breast tissue as part of a mastectomy. Unlessotherwise specified, or made clear from the context, it should be moregenerally understood that the system 100 can address challengestypically associated with manual techniques for excision of tissue inany one or more of various different procedures that are inherentlythree-dimensional in nature and of which a mastectomy is just oneexample. For example, the system 100 can address challenges associatedwith removing a substantially round cross-section (along or one or moreplanes) of tissue sufficiently pliable to be suctioned or otherwiseconformed into a predetermined shape useful for precise excision of thetissue, as described in greater detail below. Further, or instead,unless otherwise specified or made clear from the context, it should beappreciated that any one or more of the devices, systems, and methodsdescribed herein can be used to facilitate allographic harvesting ofskin from a cadaver, with such harvested skin being useful in certaintypes of reconstructive procedures, including certain types of breastreconstruction.

In use, as described in greater detail below, the cup 102 can be placedover a breast of a patient as part of a mastectomy, and the breast ofthe patient can be drawn toward the cup 102 through suction applied by asuction source 115 in fluid communication with the cup 102 such thatskin along the breast conforms substantially to the cup 102. As alsodescribed in greater detail below, with skin along the breastsubstantially conforming to the cup 102, the controller 106 can controlthe actuator 109 to move the cutting tip 110 along the three-dimensionalcontour 111 at one or more predetermined distances from the cup 102. Thecutting tip 110 can remove tissue along the three-dimensional contour111 to form a skin envelope. That is, through conformation of the skinto the cup 102, the cup 102 can define a three-dimensional coordinatesystem that accounts for variations in breast size and shape and is,thus, useful for accurately positioning the cutting tip 110 to removebreast tissue along the three-dimensional contour 111.

The cup 102 can have at least one surface 112 defining a volume 114, afirst opening 116, and a second opening 118. As used herein, the volume114 of the cup 102 shall be understood to include a three-dimensionalspatial region within which the breast tissue is to be separated fromskin by the cutting tip 110 moving along the three-dimensional contourand, as a specific example, the volume 114 can extend from the firstopening 116 to the second opening 118. In general, the volume 114 can bepositionable about a breast of a patient with the at least one surface112 of the cup 102 facing a skin surface of the breast, and the firstopening 116 circumscribing the breast of the patient. The cutting head104 can extend into the volume 114 through the second opening 118. Withthe volume 114 positioned about the breast of the patient and the firstopening 116 circumscribing the breast of the patient, at least thecutting tip 110 can extend into the volume 114, and the actuator 109 cancontrol movement of the cutting tip 110 within the volume 114.

The first opening 116 and the second opening 118 can be sized andoriented relative to one another in any of various differentorientations suitable for, among other things, facilitating assembly ofthe system 100, for robust positioning of the cutting head 104 relativeto the breast, and/or for suitably accommodating the size and shape ofthe breast of the patient. For example, the first opening 116 can have afirst area and the second opening 118 can have a second area, with thefirst area generally being sized for circumscribing the breast and thesecond area generally being sized for facile manipulation by a physicianto secure the cutting head 104 to the cup 102. Additionally, oralternatively, the first opening 116 and the second opening 118 can besubstantially parallel to facilitate accurately positioning the cuttinghead 104 relative to the chest wall of the patient.

The at least one surface 112 of the cup 102 can provide one or morespatial boundaries within the volume 114 and, more specifically, can atleast partially define a three-dimensional contour within the volume114. In general, the actuator 109 can control movement of the cuttingtip 110 along the three-dimensional contour 111 within the volume 114 toremove tissue within the volume 114. As used herein, thethree-dimensional contour 111 within the volume 114 can include a set ofthree-dimensional spatial coordinates or other spatial references that,collectively, define an outline of a closed, three-dimensional shapewithin the volume 114. For example, the closed, three-dimensional shapecan be derived from interpolation of a set of three-dimensional spatialcoordinates.

The three-dimensional contour 111 can include a closed shapesubstantially similar to the shape of the volume 114, but spaced apartfrom the at least one surface 112 at one or more predetermineddistances. Because the skin along the breast of the patient conforms tothe at least one surface 112 of the cup 102 (e.g., through theapplication of a vacuum, as described in greater detail below) as thecutting tip 110 moves within the breast to remove tissue along thethree-dimensional contour, it should be appreciated that the spacingbetween the at least one surface 112 of the cup 102 and thethree-dimensional contour within the volume 114 generally corresponds tothickness of the skin envelope being formed during the mastectomy. Thus,to form a skin envelope of a desired thickness, the spacing between theat least one surface 112 of the cup 102 and the three-dimensionalcontour 111 within the volume 114 can be defined by one or morepredetermined distances from the at least one surface 112 of the cup102.

In certain implementations, the one or more predetermined distances canbe fixed such that the resulting thickness of the skin envelope is alsofixed (e.g., to facilitate compliance with a standard). In otherinstances, however, the one or more predetermined distances can bevaried to account for differences in skin thickness between patientsand/or to account for variations in skin thickness along the breast of agiven patient. For example, the one or more predetermined distancesbetween the three-dimensional contour 111 and the at least one surface112 of the cup 102 can be input by a physician (e.g., throughinteraction with the user interface 107) as part of preparation for amastectomy. It should be appreciated that the one or more predetermineddistances input by the physician can be based on measurement and/orobservation and, more generally, can facilitate formation of a skinenvelope according to any one or more of a variety of clinicalconsiderations associated with a reduced likelihood of complications.

The volume 114, the first opening 116, or both, can at least partiallyconform to a shape of the breast of the patient prior to the mastectomy.In general, it should be appreciated that an increased degree ofconformity can facilitate controlling position of skin of the breastalong the at least one surface 112 during a mastectomy. Thus, in certaininstances, the cup 102 can be selected from one of a plurality ofdifferent predetermined sizes, with the selected size providing thehighest degree of conformity between the at least one surface 112 of thecup 102 and skin of the breast of the patient. Continuing with thisexample, the plurality of different predetermined sizes can spanvariations in one or more dimensions to accommodate variations in breastsize among the patient population. In some implementations, the cup 102can be formed (e.g., molded) to conform to the specific size and shapeof the breast of the patient.

In general, one or more of the volume 114 and the first opening 116 canhave any one or more shapes having at least some degree of conformitywith the breast of the patient. For example, one or more of the volume114 and the first opening 116 can have certain symmetric features aboutone or more planes to approximate complementary symmetry of the breast.Such symmetric features can facilitate placement of the volume 114relative to the breast and/or to facilitate positioning the cutting tip110 within the volume 114. Additionally, or alternatively, suchsymmetric features can facilitate controlling dimensional tolerances ofthe volume 114 and, thus, dimensional tolerances of the skin envelopeformed based on the volume 114. For example, one or more of the volume114 and the first opening 116 can be symmetric about at least one plane120 intersecting (e.g., perpendicular to) one or more of the firstopening 116 and the second opening 118. Still further or instead, across-section of the volume 114 in at least one plane 122 parallel tothe first opening 116 can be curvilinear, which can be useful forapproximating contours of the breast. For example, the cross-section ofthe volume 114 in the at least one plane 122 parallel to the firstopening 116 can be substantially elliptical (e.g., substantiallycircular).

In specific implementations, at least a portion of the volume 114 can beconcave to at least partially envelop the breast. For example, a concaveportion of the volume 114 can have a two-dimensional curvilinear profile(e.g., an arc) in the at least one plane 120 perpendicular to the firstopening 116 to approximate a similar, complementary profile of thebreast. As an additional or alternative example, the volume 114 can beshaped as a spherical dome having the first opening 116 as a base. Aspherical dome can be useful, for example, for facilitating mapping thevolume 114 to a spherical coordinate system. In certain instances, aspherical dome can provide a physician with a readily appreciablespatial framework for identifying the one or more predetermineddistances defining the three-dimensional contour 111 along which thecutting tip 110 is moved.

Additionally, or alternatively, the at least one surface 112 of the cup102 can be substantially rigid. More specifically, the at least onesurface 112 can retain a predetermined shape upon exposure to vacuumpressure (e.g., a partial vacuum). As used herein, exposure to vacuumpressure should be understood to refer to a pressure below standardatmospheric pressure of 101.325 kPa. Thus, in use, the at least onesurface 112 can retain a predetermined shape as vacuum pressure isapplied between the at least one surface 112 and skin of the breast ofthe patient while an outer surface of the cup 102 is under atmosphericpressure. Continuing with this example, with the at least one surface112 retaining the predetermined shape as the vacuum pressure is applied,the skin of the breast of the patient can be drawn toward the at leastone surface 112. Because the at least one surface 112 remains in a fixedposition, the skin of the breast of the patient can be reliablypositioned along the at least one surface 112, thus facilitatingremoving breast tissue based on a three-dimensional coordinate systemdefined by the predetermined shape of the at least one surface 112.

In some implementations, the at least one surface 112 of the cup 102 caninclude a textured pattern. In general, the textured pattern can resistrelative movement between the at least one surface 112 and skin incontact with the at least one surface 112. The textured pattern caninclude, for example, a plurality of bumps, undulations, or otherstructural features extending in a direction toward the volume 114.

Additionally, or alternatively, an adhesive can be disposed along the atleast one surface 112 of the cup 102 to facilitate retaining skin of thebreast of the patient in a fixed position in contact with the at leastone surface 112 of the cup 102 throughout a mastectomy. For example, theadhesive can be disposed along only a portion of the at least onesurface 112 of the cup 102. As compared to using the adhesive along theentirety of the at least one surface 112 of the cup 102, using theadhesive along only a portion of the at least one surface 112 canfacilitate separating the at least one surface 112 of the cup 102 fromskin of the breast of the patient following the mastectomy. Further, orinstead, the adhesive can include a cooling gel and, more generally, cancarry heat away from the surface of the skin to mitigate the impact ofheat that may be generated by operation of the cutting tip 110 incertain implementations.

The coupling 108 can be disposed on the cup 102 and, in general, can bereleasably securable to the cutting head 104 to establish sealed fluidengagement between the cup 102 and the cutting head 104. The coupling108 can be adjacent to the second opening 118 of the cup 102 tofacilitate securing the coupling 108 to the cutting head 104 with thecutting head 104 positioned through the second opening 118 of the cup102. For example, the coupling 108 can include one or more features tofacilitate moving the cutting head 104 through the second opening 118 asthe system 100 is prepared for a mastectomy.

The releasable engagement between the coupling 108 and the cutting head104 can be useful, for example, for separating the cup 102 from thecutting head 104, as can be advantageous for replacing the cup 102between procedures. Additionally, or alternatively, separating the cup102 from the cutting head 104 can be useful for selecting a size of thecup 102 appropriate for the patient (e.g., selecting the size of the cup102 from a plurality of predetermined sizes of the cup and/or selectinga cup 102 customized to match the size and shape of the breast of thepatient). As used herein, the sealed engagement between the coupling 108and the cutting head 104 can include substantially sealed fluidcommunication such that biological material does not pass through thesecond opening 118 as the cutting tip is used to separate tissue fromskin during a procedure.

The sealed engagement between the at least one portion of the coupling108 and the cutting head 104 should be understood to facilitate theestablishment of at least a partial vacuum between the cup 102 and skinalong the breast of the patient during the mastectomy. That is, with thecoupling 108 and the cutting head 104 in sealed engagement and with thefirst opening 116 circumscribing the breast of the patient and the cup102 positioned along the chest wall of the patient, suction can beapplied through a suction lumen 119 defined by the cutting head 104 andin fluid communication with the suction source 115. Suction applied inthis way can form at least a partial vacuum in the volume 114 betweenskin of the breast of the patient and the at least one surface 112 ofthe cup 102. With the cup 102 formed of a sufficiently rigid material,the at least one surface 112 of the cup 102 can remain substantiallynondeformed in the presence of the suction and skin of the breast of thepatient can be drawn toward the at least one surface 112 of the cup 102.The result, therefore, of application of suction by the suction source115 is that skin of the breast of the patient is drawn toward the atleast one surface 112 of the cup 102 in a predictable and repeatablemanner. Thus, as described in greater detail below, suction applied bythe suction source 115 can be useful for addressing thethree-dimensional challenges associated with accurately forming a skinenvelope as part of a mastectomy.

In general, the coupling 108 can include one or more mechanical featuresengageable with one or more complementary features of the cutting head104. More generally, the coupling 108 can be releasably securable to thecutting head 104 through any of various different known mechanicalconnections. For example, the coupling 108 and the cutting head 104 caninclude complementary threaded features such that the cup 102 can beconnected to the cutting head 104 by screwing the coupling 108 tocomplementary grooves defined by the cutting head 104. Additionally, oralternatively, the coupling 108 and the cutting head 104 can besecurable to one another via any one or more of an interference fit,complementary magnetic materials, a clip, etc.

The cup 102 can, further or instead, include a transmitter 124 disposedalong the cup 102. The transmitter 124 can include information relatedto the cup 102, such as information useful for preparing the system 100for use in performing a mastectomy. The information associated with thetransmitter 124 can include, for example, information related to safety.In use, the information related to the cup 102 can be transmitted fromthe transmitter 124 to the controller 106, where the information can beused as part of setting up the system 100.

In certain implementations, the transmitter 124 can include informationrelated to verification of a source of the cup 102. Such informationrelated to the source of the cup 102 can include, for example, aproprietary code useful for verifying that the cup 102 is a genuine partintended for use with the system 100. Further, or instead, thetransmitter 124 can include information related to previous use of thecup 102. For example, the transmitter 124 can include a counterincrementable upon each connection of the cup 102 to the cutting head104. Such information regarding previous use of the cup 102 can increasethe likelihood of compliance with regulations and/or guidelinesassociated with reuse of the cup 102. As an example, upon connecting thecup 102 to the cutting head 104, the information related to the numberof uses of the cup 102 can be transmitted to the controller 106 forverification (e.g., on a central database in communication with thecontroller 106) that the cup 102 is in compliance with regulationsregarding previous use (e.g., that the cup 102 has not been previouslyused).

In some implementations, the transmitter 124 can include sizeinformation related to the cup 102. The size information can correspondto the size and shape of the volume 114 of the cup 102. Morespecifically, the size information can include three-dimensionalcoordinates and/or dimensions of the at least one surface 112 of the cup102. The size information can be transmitted to the controller 106 and,as described in greater detail below, the controller 106 can limitmovement of the cutting tip 110 within the volume 114 of the cup 102based on the size information received from the transmitter 124.

The transmitter 124 can be activatable to transmit the informationrelated to the cup to a remote receiver, such as the controller 106. Forexample, the transmitter 124 can include a passive RFID tag and, in use,electromagnetic energy directed to the passive RFID tag can activate thepassive RFID tag to transmit the information from the transmitter 124 tothe controller 106. As a specific example, the electromagnetic energycan be transmitted to the passive RFID tag from the cutting head 104coupled to the cup 102. In general, the passive RFID tag, or othersimilar passive techniques for storing and transmitting information fromthe cup 102 to the controller 106, can facilitate forming the cup 102 asa limited-use component (e.g., a single-use component or some otherpredetermined number of uses). A limited-use component can reduce thelikelihood of complications associated with unintended deformation ordamage of the cup 102 through repeated uses, such as may occur over thecourse of a large number of uses.

The system 100 can, in some instances, include a gasket 126 disposedalong the first opening 116 of the cup 102 and, in use, the gasket 126can be in contact with skin of the patient along the chest wall. Thegasket 126 can be formed of a material differing from the materialforming one or more portions of the cup 102 to provide certainmechanical advantages. For example, the gasket 126 can be formed of apliable material (e.g., silicone, rubber, or a combination thereof),such as a material that is more pliable than the material along the atleast one surface 112 of the cup. The pliability of the gasket 126 can,in some instances, provide mechanical resistance to inadvertent movementof the cup 102 along skin of the patient during a procedure.Additionally, or alternatively, the gasket 126 can be pliable to atleast partially conform to the chest wall of the patient to provide atleast a partial fluid seal between the cup 102 and the chest wall.Continuing with this example, the seal provided by the gasket 126 canfacilitate the formation of at least a partial vacuum useful for drawingskin along the breast of the patient toward the at least one surface 112of the cup 102.

In certain implementations, the gasket 126 can be releasablypositionable along the first opening 116. That is, the gasket 126 can bepositioned along the first opening 116 of the cup 102 prior to aprocedure. Such releasable positioning of the gasket 126 can facilitateseparate sterilization of the gasket 126 and the cup 102, which can beuseful, for example, in instances in which the gasket 126 is formed of amaterial sterilizable according to a technique that is incompatible withsterilization of material forming the cup 102. Additionally, oralternatively, the releasable positioning of the gasket 126 on the cup102 can be useful for selecting a material that is less likely toirritate skin of a given patent (e.g., in instances in which the patientmay have a sensitivity, such as an allergy, to a given type ofmaterial).

In general, the cutting tip 110 can be positionable along the breast ofthe patient to separate tissue. More specifically, the cutting tip 110can be positionable along the three-dimensional contour 111 to separatethe tissue to be removed from the that tissue that will remain to formthe skin envelope. The separation of the tissue in this manner can beachieved, for example, through the application of any one or more formsof energy that can be locally controlled along the three-dimensionalcontour 111. Thus, for example, the cutting tip 110 can be actuatable toapply any manner and form of mechanical energy, thermal energy,electrical energy, chemical energy, and combinations thereof to separatethe tissue. For the sake of clarity of explanation, however, the cuttingtip 110 is described below in the context of electrosurgery, which canoffer any of various different advantages in the formation of a breastenvelope. Examples of advantages of electrosurgery using the cutting tip110 include, but are not limited to, separation of tissue whilecontrolling bleeding, formation of the cutting tip 110 with a formfactor suitable for movement within the volume 114 defined by the atleast one surface 112 of the cup 102, and local control of energy with alow likelihood of collateral tissue damage.

The cutting tip 110 can include a resistance element 128, which can beany of various different shapes suitable for maneuverability along thethree-dimensional contour 111 over the course of a mastectomy. Forexample, the resistance element 128 can be substantially needle-like.Further, or instead, the resistance element 128 can be formed of any oneor more of various different sterilizable, biocompatible, and highlyconductive materials, of which stainless steel is one example. Theresistance element 128 may, additionally or alternatively, include acoating, such as may be useful for reducing the likelihood of adhesionof tissue to the resistance element 128. Thus, for example, theresistance element 128 can include a polytetrafluorethylene coating(e.g., Teflon™, available from The Chemours Company of Wilmington,Del.).

In certain implementations, the resistance element 128 can be anelectrode (e.g., monopolar or bipolar) positionable into electricalcontact with tissue along the three-dimensional contour 111. Theresistance element 128 can be in electrical communication with thecontroller 106 and, in use, the controller 106 can generate and controlelectrical energy (e.g., in the form of high frequency alternatingcurrent, such as RF electrical energy) to be passed into the tissue viacontact between the tissue and the resistance element 128. The energydelivered into the tissue through the resistance element 128 canvaporize or otherwise destroy the tissue locally to form an incision.Additionally, or alternatively, the energy delivered to the tissuethrough the resistance element 128 can coagulate the tissue, which canbe useful for reducing blood loss from the patient.

The cutting tip 110 can define a track 130, and the resistance element128 can be movable back and forth along the track 130. For example,electrical energy can be delivered to the tissue via the resistanceelement 128 as the resistance element 128 moves back and forth along thetrack 130. Moving the resistance element 128 along the track 130 aselectrical energy is delivered to the tissue can be useful for removingtissue through application of a plurality of slices along thethree-dimensional contour 111. Slicing in this way can advantageouslyfacilitate following the three-dimensional contour 111, as the angle oforientation of each slice can be varied as necessary to conform to thethree-dimensional contour 111.

In some implementations, the cutting tip 110 can include one or moresensors 132 in electrical communication with the controller 106. The oneor more sensors 132 can be, for example, adjacent to the resistanceelement 128 to an extent sufficient to measure one or more physicalparameters in the vicinity of the resistance element 128. As describedin examples below, the one or more physical parameters measured by theone or more sensors 132 can be useful for positioning the cutting tip110 and/or for controlling energy delivery to the resistance element128.

The one or more sensors 132 can advantageously include one or moreposition sensors to sense a distance from the cutting tip 110 to the atleast one surface 112 of the cup 102 defining the volume 114 and thefirst opening 116. As should be readily understood, because the cup 102remains stationary with respect to the breast (e.g., through suction orother forces holding the cup 102 in contact with skin of the breast) andthe three-dimensional contour 111 is defined by one or morepredetermined distances from the at least one surface 112 of the cup102, the sensed distance from the cutting tip 110 to the at least onesurface 112 of the cup 102 can be advantageously used as feedback forpositioning the cutting tip 110 to form a skin envelope along thethree-dimensional contour 111. In certain implementations one or moreposition sensors can be useful for repositioning the cutting tip 110 tospecific coordinates along the three-dimensional contour 111, such as inthe event of an interruption in the mastectomy. Thus, more generally,the cup 102 can define a local coordinate system, and the one or moresensors 132 can provide feedback useful for positioning the cutting tip110 along such a coordinate system.

The one or more sensors 132 can include any of various different sensorssuitable for sensing the position of the cutting tip 110 relative to theat least one surface 112 of the cup 102. As an example, the one or moresensors 132 can include a magnetic position sensor responsive to amagnetic field generated by one or more magnetic elements carried in oron the cup 102 to determine a position of the one or more sensors 132.Further or instead, the one or more sensors 132 can include an opticalsensor, an acoustic sensor, or a combination thereof. In certainimplementations, the cup 102 can carry one or more elements useful as alandmark detectable by the one or more sensors 132. For example, inimplementations in which the one or more sensors 132 include an opticalsensor, the cup 102 can include a band of optically opaque materialdemarcating a boundary relative to the chest wall to reduce thelikelihood of inadvertently moving the cutting tip 110 into contact withthe chest wall, where manual dissection of tissue may be desirable.

In some instances, the one or more sensors 132 can include one or moretissue sensors useful for detecting whether the cutting tip 110 is incontact with tissue. An example of a tissue sensor is a pressure sensorpositionable to detect contact pressure (e.g., through use of a straingauge or other similar method) between the cutting tip 110 and tissue.An additional or alternative example of a tissue sensor is a capacitancesensor, with a change in capacitance being indicative of contact betweenthe cutting tip and tissue.

Detecting contact between the cutting tip 110 and the tissue at thetreatment site can be useful, for example, for tracking progress of theformation of the skin envelope along the three-dimensional contour 111.Further, or instead, detecting contact between the cutting tip 110 andtissue along the three-dimensional contour 111 can be useful forefficiently achieving proper orientation of the cutting tip 110 alongthe three-dimensional contour 111. As an example, the actuator 109 canmove the cutting tip 110 according to one or more predeterminedprogressions of movement until the one or more sensors 132 detectcontact with tissue, thus indicating that the cutting tip 110 is in asuitable position for cutting tissue along the three-dimensional contour111. Still further or instead, detecting contact between the one or moresensors 132 and tissue can serve as a basis for enabling or disablingdelivery of electrical energy to the resistance element 128, which canreduce the likelihood of unintended tissue damage.

In some implementations, the one or more sensors 132 can include a bloodsensor, examples of which include any of various different sensors knownin the art for detecting the presence of blood in a surgical settingand, thus, include an optical sensor, an acoustic sensor, an impedancesensor, or combinations thereof. A blood sensor carried on the cuttingtip 110 can be useful, for example, for detecting proper placement ofthe cutting tip 110 along the skin envelope being formed along thethree-dimensional contour 111. Additionally, or alternatively, the bloodsensor can be useful as a feedback parameter for controlling coagulationalong the skin envelope.

In certain implementations, the one or more sensors 132 can include atemperature sensor, such as a thermocouple. The temperature sensor canbe useful for detecting contact between the cutting tip 110 and tissue,with a change in temperature being indicative of contact. Further, orinstead, the temperature sensor can be useful for providing feedbackregarding the progress of the incision and/or coagulation along the skinenvelope being formed along the three-dimensional contour 111.

Additionally, or alternatively, the one or more sensors 132 can includea moisture sensor. The moisture sensor can be useful for detectingwhether the cutting tip 110 is in a fluid, such as blood or saline. Insome instances, the presence of moisture can be a useful indicator thatthe cutting tip 110 is positioned in an environment in which energy canbe safely delivered to the cutting tip 110. For example, the detectedmoisture can act as a medium for dissipating energy delivered to thecutting tip 110, with such energy dissipation being generally useful forprotecting tissue that is beyond an area targeted by the cutting tip110.

In some implementations, the one or more sensors 132 can include acombination of sensors such that the cutting tip 110 is a blood-seekingtip. As an example, in instances in which the one or more sensors 132include a blood sensor, a temperature sensor, and a moisture sensor, thesignals received from these one or more sensors 132 can be combined toprovide an indication of a direction in which the cutting tip 110 ismore likely to encounter blood. In the context of formation of a skinenvelope along the three-dimensional contour 111, the tissue to betargeted along the three-dimensional contour 111 at a given time-step isgenerally characterized by blood as the tissue is separated from skinforming the skin envelope. That is, the skin envelope is formed througha progression of cuts, with the position of the next cut in theprogression being characterized by the presence of blood. Thus,instances in which the cutting tip 110 is a blood-seeking tip, feedbackfrom the one or more sensors 132 can provide a basis for actuating oneor both of the pivot arm 136 and the extension arm 138 to position thecutting tip 110 in the vicinity of blood. Automated or semi-automatedmovement of the cutting tip 110 in a blood-seeking manner can be useful,for example, for achieving efficient movement of the cutting tip 110relative to the three-dimensional contour 111 as the skin envelope isformed.

The cutting tip 110 can, in certain instances, define one or moresuction channels 134 adjacent to the resistance element 128. The one ormore suction channels 134 can be useful, for example, for removingvapor, coagulated matter, or other material formed or otherwise presentas electrical energy is directed from the resistance element 128 totissue. Such suction can be useful, for example, for reducing thelikelihood that extraneous material will interfere with forming anincision through contact between the resistance element 128 and tissue.In use, the one or more suction channels 134 can be in fluidcommunication with a suction source, such as wall suction typicallyavailable in an operating room. Further or instead, the one or moresuction channels 134 can be coupled to a suction source that isregulated to provide a controlled amount of suction, such as to providesuction based on whether electrical energy is being delivered to theresistance element 128.

In general, the actuator 109 can be in electrical communication with thecontroller 106 and controllable to move the cutting tip 110 along thethree-dimensional contour 111. For example, the actuator 109 can movethe cutting tip 110 parallel to the at least one surface 112 of the cup102. Further or instead, the actuator 109 can move the cutting tip 110to orient the resistance element 128 in a particular manner (e.g.,tangential) relative to the three-dimensional contour 111 along whichthe skin envelope is to be formed. Unless otherwise specified or madeclear from the context, it should be appreciated that the actuator 109can be controlled to move the cutting tip 110 based at least in part onfeedback from the one or more sensors 132.

In certain implementations, the actuator 109 can be actuatable to movethe cutting tip 110 through at least three degrees of freedom within thevolume 114 defined by the at least one surface 112 of the cup 102. Forexample, the actuator 109 can include a pivot arm 136 and, additionallyor alternatively, an extension arm 138 moveable in coordination with oneanother to move the cutting tip 110 along the three-dimensional contour111. While movement of the cutting tip 110 is described below withrespect to actuation of the actuator 109 and actuation of the pivot arm136, it should be appreciated that such description is for the sake ofclarity of explanation and that the actuator 109 can include any mannerand number of members actuatable to achieve any manner and form ofmovement of the cutting tip 110 within the volume 114. Thus, in certaininstances, the actuator 109 can include additional or alternativemembers suitable for moving the cutting tip 110 along a plurality ofdegrees of freedom (e.g., six degrees of freedom) within the volume 114.

The pivot arm 136 can be rotatable about a first axis 140 defined by thepivot arm 136 to control a position of the cutting tip 110 in the atleast one plane 122 parallel to the first opening 116. For example, thepivot arm 136 can include an electric rotary actuator or other similaractuator for converting electrical energy to mechanical energy forrotating the pivot arm 136. In general, the pivot arm 136 can be coupledto the extension arm 138 such that rotation of the pivot arm 136 resultsin rotation of the extension arm 138.

The extension arm 138 can be axially moveable along a second axis 142defined by the extension arm 138. For example, the extension arm 138 caninclude telescoping portions moveable relative to one another along thesecond axis 142 to change a length of the extension arm 138 along thesecond axis 142. The extension arm 138 can include a linear actuator orother similar actuator) for converting electrical energy to mechanicalenergy to change the length of the extension arm 138 along the secondaxis 142.

In certain implementations, the pivot arm 136 and the extension arm 138can be moveable relative to one another to change an included angle θbetween the first axis 140 and the second axis 142. For example, theextension arm 138 can be rotatable in at least one direction about apivot joint 144 between the pivot arm 136 and the extension arm 138. Thepivot joint 144 can include an electric rotary actuator or other similaractuator for converting electrical energy to mechanical energy forchanging the included angle θ between the first axis 140 and the secondaxis 142.

While movement of the extension arm 138 in the volume 114 can beachieved through a combination of actuators disposed along the extensionarm 138 to apply force directly to the extension arm 138, it should beappreciated that other types of actuation of the extension arm 138 areadditionally or alternatively possible. For example, given sizeconstraints associated with the volume 114, actuation components may beadvantageously positioned outside of the volume 114. As described ingreater detail below, a combination of springs, cables, or other similarmechanical components can be used along with or instead of the actuationcomponents to position the extension arm 138.

The extension arm 138 can be substantially rigid to resist deformationunder typical forces experienced by the extension arm 138 as the cuttingtip 110 is moved along and positioned relative to the three-dimensionalcontour 111 to remove tissue. That is, the extension arm 138 can besubstantially rigid under a variety of states of telescoping extensionrequired to position the cutting tip 110 relative to thethree-dimensional contour 111. Thus, for example, the extension arm 138can be substantially rigid such that, under forces exerted on theextension arm 138 by any of various different actuators and/or tissueduring a procedure, the position of the extension arm 138 (and, thus,the position of the cutting tip 110) remains within an error toleranceacceptable for a given procedure, which can be less than about ±0.5 mmfor certain procedures and, more specifically, can be completely rigidfor certain procedures. Accordingly, with little or no movement of theextension arm 138 in response to forces exerted on the extension arm138, it should be appreciated the substantial rigidity of the extensionarm 138 can be useful for facilitating accurate determination of aposition of the cutting tip 110.

In general, the controller 106 can include one or more processors 148and a non-transitory, computer readable storage medium 150. Thecontroller 106 can be in electrical communication at least with theactuator 109 and the cutting tip 110. The computer readable storagemedium 150 can have stored thereon computer executable instructions forcausing the one or more processors to carry out any one or more of themethods described herein for dissecting tissue along thethree-dimensional contour 111 to form a skin envelope. Further, orinstead, the computer readable storage medium 150 can have storedthereon computer executable instructions for causing the one or moreprocessors to carry out any one or more of the methods described hereinfor identifying one or more features of the cup 102 coupled to thecutting head 104. Still further or instead, the computer readablestorage medium 150 can have stored thereon computer executableinstructions for causing the one or more processors to receive at leastone user input (e.g., through the user interface 107), with the userinput corresponding to any of various different parameters useful foraccurate formation of a skin envelope. Examples of such parameters caninclude, without limitation, information regarding the size and/or shapeof the cup 102 and, further or instead, can include one or morepredetermined distances from the at least one surface 112 of the cup 102defining the volume 114 and the first opening 116.

FIG. 7 is a flowchart of an exemplary method 170 of removing tissue froma patient. Unless otherwise specified or made clear from the context, itshould be appreciated that the exemplary method 170 can be carried outusing any one or more of the devices, systems, and methods describedherein. Thus, for example, the exemplary method 170 can be carried outby the controller 106 (FIG. 1) and, more specifically, can beimplemented as instructions stored on the computer readable storagemedium 150 (FIG. 1) and carried out by the one or more processors 148(FIG. 1).

The exemplary method 170 can include receiving 172 an identificationsignal indicative of a size of a cup defining a volume, determining 174a three-dimensional contour within the volume of the cup, sending 176one or more control signals to an actuator to position a cutting tipalong the three-dimensional contour, and sending 178 an activationsignal to the cutting tip to dissect tissue along the three-dimensionalcontour to form at least a portion of a skin envelope. As described ingreater detail below, determining 174 the three-dimensional contour canbe based on the received 172 identification signal indicative of thesize of the cup. Accordingly, among other advantages, the exemplarymethod 170 can be useful for reliably accommodating three-dimensionalvariations that exist among breasts in a patient population, thusfacilitating improved accuracy of skin envelopes formed duringmastectomies.

In general, receiving 172 the identification signal indicative of thesize of the cup can include receiving any manner and form of signalassociated with the cup. Thus, as used herein, the identification signalcan include any manner and form of electrical signal, optical signal,mechanical signal, or combination thereof, derived from information orfeatures associated with (e.g., carried on) the cup. The identificationsignal indicative of the size of the cup can be useful, for example, forsetting one or more boundary conditions for movement of the cutting tipduring a mastectomy. That is, the cup can be selected from among aplurality of sizes such that the volume defined by the cup cansubstantially match the size of the breast of the patient, and theidentification signal can provide a controller with relevant sizeinformation associated with the cup selected for a given procedure.Further, or instead, the identification signal indicative of the size ofthe cup can be useful in combination with one or more other signals(e.g., a manual input through a user interface) for the purpose of sizeverification or verification of other information such as authenticationof the cup as a genuine part meeting, among other criteria, sizetolerances, material properties, etc.

In certain implementations, receiving 172 the identification signal caninclude sending an interrogation signal to the cup. For example, theinterrogation signal can be sent from the cutting head, or anotherreusable portion of the system, to the cup (e.g., upon establishing amechanical connection between the cutting tip and the cup). Theinterrogation signal can include any one or more of an electricalsignal, an optical signal, and a mechanical signal. Thus, for example,the interrogation signal can include an RF signal directed to a passiveRFID tag carried on the cup according to any one or more of the variousdifferent methods described herein.

The identification signal can include, in some instances, informationindicative of use history of the cup. For example, the use history ofthe cup can be stored on the cup itself. Additionally, or alternatively,the use history of the cup can be stored in a database on thecontroller, at a remote server, or a combination thereof. Theidentification signal can include a unique identifier of the cup (e.g.,a serial number), and the use history of the cup can be updated uponreceiving the identification signal (e.g., in response to aninterrogation signal or otherwise detecting a connection between the cupand the cutting head). In certain applications, it can be desirable tolimit the number of uses of the cup (e.g., to reduce the likelihood ofunintended failure or deformation of the cup). Thus, in certaininstances, sending 176 the one or more control signals to the actuatorcan be based on whether the use history of the cup is below apredetermined threshold. By way of example, in the case of single-usedevices, it should be understood that the threshold is one such that,upon subsequent connection of the cup following a single use, sending176 the one or more control signals can be blocked until the cup isreplaced with a new cup.

In general, the three-dimensional contour can be determined 174 based onthe received 172 identification signal indicative of the size of thecup. That is, the identification signal can provide location informationregarding the at least one surface defining the volume of the cup, andthe three-dimensional contour can be defined relative to the knownposition of the at least one surface. With skin of the breast heldagainst the at least one surface defining the volume of the cup (e.g.,through suction, an adhesive, or a combination thereof), spacing betweenthe three-dimensional contour and the at least one surface defining thevolume of the cup substantially defines the thickness of the skinenvelope formed according to the exemplary method 170. Thus, it shouldbe appreciated that determining 174 the three-dimensional contour basedon the received 172 identification signal indicative of the size of thecup can be useful for efficiently and reliably accounting for variationsin three-dimensional anatomical structures—with such variations beingcharacteristic of breasts in the patient population.

The spacing between the three-dimensional contour and the at least onesurface defining the volume of the cup can be implemented according toany one or more of the techniques described herein. Thus, for example,the three-dimensional contour can be parallel to and spaced apart fromthe at least one surface of the cup. Additionally, or alternatively, thethree-dimensional contour can be spaced apart from the at least onesurface of the cup at one or more predetermined distances. Further, orinstead, determining 174 the three-dimensional contour within the volumecan include receiving one or more predetermined distances from an inputdevice operated by the physician.

In general, sending 176 the one or more control signals to the actuatorcoupled to the cutting tip can include any combination of controlsignals associated with positioning the cutting tip. As used herein,positioning the cutting tip should be understood to include locating thecutting tip along the three-dimensional contour, orienting the cuttingtip relative to the three-dimensional contour, or a combination thereof.More specifically, given the three-dimensional nature of the skinenvelope being formed, it is generally desirable to send one or morecontrol signals to locate the cutting tip along three-dimensionalcontour in a specific orientation at the given location. That is, acombination of location and orientation of the cutting tip can becontrolled to remove tissue along a complex geometry with little or nocollateral damage to tissue forming the skin envelope.

In some applications, the cutting tip can be oriented to dissect tissuein a direction tangential to the three-dimensional contour at a givenlocation. As used herein, tangential shall be understood to includegeometrically tangential orientations as well as orientations deviatingslightly from the geometric ideal but that would nevertheless beunderstood by a person of ordinary skill in the art to be tangential tothe three-dimensional contour within the typical dimensional resolutionof electromechanical control. Thus, for example, it should be understoodthat the cutting tip can define a tip axis (e.g., extending through aresistance element of the cutting tip), and the one or more controlsignals sent 175 to the actuator can position the tip axis tangent tothe three-dimensional contour. Orienting the cutting tip in a directiontangential to the three-dimensional contour can be a particularly usefulsolution for controlled dissection of tissue along a three-dimensionalcontour, as a plurality of tangential dissections can be executed insequence to approximate the three-dimensional contour along which theskin envelope is sought to be formed.

In certain implementations, the actuator can have at least three degreesof freedom, and sending 176 the one or more control signals to theactuator can include sending a respective control signal associated witheach of the three degrees of freedom of the actuator for movement alongeach axis of a three-dimensional coordinate system. It should be readilyunderstood that additional control signals can be associated withadditional degrees of freedom. Thus, for example, additional degrees offreedom can be associated with rotation about each axis of athree-dimensional coordinate system (e.g., roll, pitch, and yaw).

Sending 178 the activation signal to the cutting tip to dissect tissuealong the three-dimensional contour can include sending the signalaccording to any one or more of various different control criteria. Inparticular, because sending 178 the activation signal can be based on anautomated or a semi-automated process, it should be understood thatcontrol criteria useful for reducing the likelihood of damage tocollateral tissue or other complications can be particularly useful. Forexample, sending 178 the activation signal can include selectivelysending the activation signal, such as upon determination that thecutting tip is appropriately positioned along the three-dimensionalcontour. Continuing with this example, the determination of whether thecutting tip is appropriately positioned along the three-dimensionalcontour can be based on feedback from any one or more of the differenttypes of sensors described herein.

The exemplary method 170 can, in some cases, include sending 179 analert signal to a user interface based on proximity of the cutting tipto a predetermined region of the volume. For example, in certainapplications, aspects of controller-based dissection using the devices,systems, and methods described herein can be combined with those ofconventional manual dissection as necessary or desirable. That is, whilecontroller-based control of movement and selective activation of thecutting tip can be useful for precise removal of tissue along certainareas of the breast, conventional manual dissection may be preferableand/or more effective along other areas of the breast. Sending 179 thealert to the user interface, therefore, can be useful for alerting thephysician that a controller-based portion of the mastectomy is completeor nearing completion, and that the remainder of the mastectomy can becarried out by the physician.

The chest wall presents a specific example of a region that may benefitfrom transitioning from controller-based dissection to manualdissection. Unlike the three-dimensional contour along the skinenvelope, dissection along the chest wall is substantiallytwo-dimensional. Such two-dimensional dissection present challenges withrespect to, among other things, access by automated devices or systems.Further, two-dimensional dissection along the chest wall is particularlywell-suited to manual dissection techniques carried out by a physicianusing conventional dissection tools, given the well-defined areolarplane that exists between the breast and the chest wall (pectoralismajor muscle fascia). Accordingly, it may be desirable to transitionfrom a controller-based dissection process to a manual dissectionprocess at a predetermined distance from the chest wall. That is,continuing with this example, sending 179 the alert to the userinterface can provide an indication to the physician that dissection iscomplete to within a predetermined distance from the chest wall. Thephysician can then complete the mastectomy using manual dissectiontechniques along a substantially two-dimensional profile.

FIG. 8 is a flowchart an exemplary method 180 of vacuum-based anchoringfor three-dimensional dissection of tissue. Unless otherwise specifiedor made clear from the context, it should be appreciated that theexemplary method 180 can be carried out using any one or more of thedevices, systems, and methods described herein. Thus, for example, theexemplary method 180 can be carried by the controller 106 (FIG. 1) and,more specifically, can be implemented as instructions stored on thecomputer readable storage medium 150 (FIG. 1) and carried out by the oneor more processors 148 (FIG. 1).

The exemplary method 180 can include receiving 182 a signal indicativeof fluid pressure in a volume at least partially defined at least onesurface of a cup, positioning 184 a cutting tip along athree-dimensional contour within the volume (e.g., the three dimensionalcontour can be spaced apart from the at least one surface of the cup atone or more predetermined distances), and selective activation 186 ofthe cutting tip to dissect tissue of a patient along thethree-dimensional contour. As described in greater detail below,selective activation 186 of the cutting tip can be based on the received182 signal indicative of fluid pressure in the volume. Accordingly, theexemplary method 180 can make beneficial use of pressure—morespecifically, vacuum pressure—in the volume to draw skin of the breastinto a known, three-dimensional profile at the surface of the cup andmaintain the skin of the breast in this known, three-dimensional profileas the tissue is dissected to form a skin envelope. That is, theexemplary method 180 can make use of vacuum pressure to facilitateachieving robust and repeatable three-dimensional positioning of skin ofthe breast as a skin envelope is formed.

In general, receiving 182 the signal indicative of fluid pressure in thevolume can include receiving any one or more of various differentsignals indicative of pressure in the volume with the cup disposed abouta breast of the patient and breast of the patient extending into thevolume. Thus, for example, the signal indicative of the fluid pressurein the volume can be a signal received from a pressure sensor in thevolume. As an example, one or more sensors on the cutting tip (e.g., theone or more sensors 132 on the cutting tip 110 in FIG. 6) can include apressure sensor, which may be useful for confirming that there issufficient vacuum pressure locally within the volume and, morespecifically, locally in the vicinity of where the next cut in aprogression of cuts will take place. While overall pressure in thevolume and a local pressure in a portion of the volume may typically bethe same, conditions may arise during the formation of a skin envelopethat can cause the local pressure to deviate from a global pressure. Forexample, one or more portions of the volume may become blocked from avacuum source as the skin envelope is formed and, under such conditions,the pressure in the volume may vary. Accordingly, a local measurement ofpressure in the vicinity of the cutting tip can be a useful safeguardagainst unintended variations in pressure. Additionally, oralternatively, receiving the signal indicative of fluid pressure in thevolume can include receiving a signal from a pressure sensor outside ofthe volume in fluid communication and/or in mechanical communicationwith the volume to provide an indication of global pressure in thevolume. In certain instances, receiving 182 the signal indicative of thepressure can include receiving a signal from one or more sensors.

In certain implementations, the signal indicative of the fluid pressurein the volume can be received 182 over a predetermined period of time(e.g., a moving temporal window). The predetermined period of time canbe useful, for example, accounting for variations in pressure, such asvariations in pressure that may occur in instances in which operatingroom suction is used as at least a portion of the suction applied to thevolume defined by the at least one surface of the cup. In certaininstances, selective activation 186 of the cutting tip may be based on afluctuation of the received pressure signal over the predeterminedperiod of time. Such a fluctuation may be indicative of, for example, anundesirable transient condition, which may result in movement of skin ofthe patient. Thus, continuing with this example, it may be useful toselectively activate 186 the cutting tip after a predetermined periodwithout fluctuations in the received pressure signal. More generally,the received 182 signal may be processed as necessary to identifyconditions in the volume suitable for selective activation 186 of thecutting tip.

In general, positioning 184 the cutting tip along the three-dimensionalcontour within the volume may be achieved according to any one or moreof the various different techniques described herein for moving acutting tip. For example, positioning 184 the cutting tip along thethree-dimensional contour within the volume may include sending one ormore control signals to an actuator directly or indirectly mechanicallycoupled to the cup and the cutting tip. In this context, the actuatorshould be understood to include any one or more of the various differentmechanisms for moving the cutting tip. Thus, for example, the one ormore control signals can move one or both of a pivot arm or an extensionarm directly or indirectly (e.g., via cables) coupled to the cuttingtip. More generally, the actuator can have a plurality of degrees offreedom, and sending the one or more control signals to actuator caninclude sending a respective control signal associated with each degreeof freedom of the actuator. Thus, for example, in instances in which theactuator has six degrees of freedom, sending the one or more controlsignals to the actuator can include sending six control signals—onecontrol signal for each degree of freedom—to the actuator. In certainimplementations, the cutting tip can define a tip axis, and the one ormore control signals sent to the actuator position the tip axis tangentto the three-dimensional contour, for example, as described above.

The three-dimensional contour can be any of the three-dimensionalcontours described herein. Thus, for example, the three-dimensionalcontour can be at least a portion of an ellipsoid or another shapeformed through rotation of a curvilinear profile about an axis.Additionally, or alternatively, the three-dimensional contour may besubstantially symmetric with respect to one or more planes bisecting thecup.

Selective activation 186 of the cutting tip can include, for example,delivering energy—such as, heat or other energy sufficient to dissecttissue—to the cutting tip based on the received 182 signal indicative offluid pressure in the volume. While the selective activation 186 of thecutting tip can be based on the received 182 signal indicative of fluidpressure in the volume, it should be appreciated that selectiveactivation 186 can further, or instead, be based on any one or moreother signals described herein. Thus, for example, the selectiveactivation 186 can be based on the received 182 signal indicative offluid pressure in the volume in addition to confirmation, based onsignals from one or more sensors on the cutting tip, that the cuttingtip is appropriately positioned relative to the skin and tissue.

In certain implementations, selective activation 186 of the cutting tipcan include delivering energy to the cutting tip based on whether thereceived 182 signal corresponds to a condition at or below apredetermined vacuum pressure in the volume. Given that sufficientvacuum pressure in the volume can draw skin of the patient toward the atleast one surface of the cup, the received 182 signal indicative of avacuum pressure in the volume can serve as a useful proxy fordetermining that skin along the breast is appropriately positionedrelative to the at least one surface of the cup, and thus relative tothree-dimensional contour, for carrying out the formation of a skinenvelope according to any one or more of the techniques describedherein. For example, the received 182 signal can form part of a controlapproach to maintain a target vacuum pressure in the volume defined bythe at least one surface of the cup, thus maintaining proper positioningof the three-dimensional contour relative to skin of the breast. As amore specific example, the received 182 signal can be used as a feedbackcontrol parameter useful for controlling a vacuum source (e.g., a vacuumpump) in fluid communication with the volume. Further, or instead, otherparameters may be useful as direct or indirect indications ofappropriate positioning of skin along the breast relative to the atleast one surface of the cup. For example, any manner and form ofoptical, thermal, electrical, and contact sensing may be used as anadditional or alternative indication of positioning of skin of thebreast relative to the at least one surface of the cup.

The exemplary method 180 can, in certain instances, include repeating188 the steps of receiving 182 the signal, positioning 184 the cuttingtip along the three-dimensional contour within the volume, andselectively 186 activating the cutting tip to dissect tissue to form askin envelope. Once the three-dimensional skin envelope is formed, aphysician may complete the mastectomy by removing tissue along the chestwall.

Referring now to FIGS. 9 and 10, an exemplary method 190 of removingbreast tissue from a patient is described below in the context of aphysician using the system 100 described in FIG. 1. However, unlessotherwise specified or made clear from the context, it should beappreciated that the exemplary method 190 can be carried out by aphysician operating on a patient using any one or more of the devicesand systems described herein.

The exemplary method 190 can include selecting 192 a cup, securing 194the cup to a cutting head, making 196 an incision in a breast of thepatient, and positioning 198 the cup about the breast of the patient. Itshould be understood that the cup can be any one or more of the variousdifferent cups described herein and, thus, can be the cup 102. Furtheror instead, the cutting head can be any one or more of the variousdifferent cups described herein and, thus, can be the cutting head 104including the actuator 109 and the cutting tip 110. For example, asshown in FIG. 10, the cutting tip 110 can be positioned adjacent to skin“S” of the breast and selectively activated to separate the skin “S” ofthe breast from tissue “T” of the breast to form a skin envelope.Suction applied via the suction lumen 119 defined by the cutting head104 can draw the skin “S” toward the cup 102 as the tissue “T” fallsaway, with the resulting separation between the skin “S” and the tissue“T” providing more space for further maneuvering the cutting tip 110 toremove additional tissue. In this way, the cutting tip 110 can beprogressively moved along the three-dimensional contour 111 (FIG. 4) andselectively activated to form the skin envelope.

Selecting 192 the cup can include selecting any one or more of thevarious different cups described herein, with the selected 192 cuphaving one or more surfaces defining a volume and a first opening.Selecting 192 the cup can include, among other things, choosing a cupapproximating the size of the patient's breast. For example, the cup canbe selected 192 from a plurality of cups spanning a range of sizes. Morespecifically, the plurality of cups can span variations in any one ormore of base width, projection (distance from the chest wall when viewedfrom a side of the breast), size of the areola complex, or any othergeometric feature of a breast. Further, or instead, selecting 192 thecup can include any manner and form of customization of the cup withrespect to the patient's breast. Accordingly, in certain instances,selecting 192 the cup can include forming the cup in the specific shapeof the patient's breast. In certain implementations, selecting 192 thecup can include providing a verification input to a user interface(e.g., a keyboard, a mouse, a touch screen, etc.) in electricalcommunication with the cutting head.

In general, securing 194 the cup to the cutting head can include atleast mechanically coupling the cutting head to the selected 192 cupsuch that movement of the cutting head is at least partially restrainedwith respect to the cup as the procedure is carried out. In certainimplementations, securing 194 the cup to the cutting head can furtherinclude establishing fluid communication between the cutting head andthe volume defined by the cup such that suction provided through thecutting head can be provided in the volume to draw skin toward the atleast one surface of the cup. Further, or instead, securing 194 the cupto the cutting head can, further or instead, include establishingelectrical or other similar type of communication between the cup and acontroller in electrical communication with the cutting head, with suchcommunication being useful for identifying the cup. The electricalcommunication can include any one or more of the various different typesof electrical communication described herein and generally useful foradditionally or alternatively verifying the size of the cup or, incertain instances, for tracking the number of uses of the cup.

Making 196 an incision in the breast of the patient forms an access sitefor the cutting tip. In certain implementations, making 196 the incisioncan include removing the areola complex of the breast. For example, thephysician can manually remove the areola complex from the breastaccording to any one or more conventional techniques.

Positioning 198 the cup about the breast of the patient can includeplacing one or more surfaces of the cup facing a skin surface of thebreast with a first opening of the cup circumscribing the breast of thepatient. In general, positioning 198 the cup about the breast of thepatient can include positioning the cup about the breast of the patientaccording to any one or more of the techniques described herein. By wayof example, therefore, positioning 198 the cup about the breast of thepatient can include placing a gasket (e.g., the gasket 126) along afirst opening defined by one or more surfaces of the cup. The gasket canbe useful, for example, for creating a substantially sealed engagementwith the chest wall when the cup is positioned over the breast.Continuing with this example, positioning 198 the cup about the breastof the patient can include forming at least a partial vacuum between theone or more surfaces of the cup and the skin surface of the breast todraw the breast toward the cup, as described above.

In certain implementations, positioning 198 the cup about the breast ofthe patient can include substantially centering the cup relative to theincision in the breast of the patient. Such substantial centering can beuseful for increasing the likelihood that the cutting tip can extendsufficiently to reach each portion of the three-dimensional contour.

In certain implementations, the exemplary method 190 can further includeoperating 199 the cutting head. In general, operating 199 the cuttinghead can include controlling the cutting tip and the actuator accordingto any one or more of the various different methods described herein.Thus, the actuator can be actuated according to any one or more of thevarious different methods described herein to move the cutting tip alongthe three-dimensional contour at one or more predetermined distancesfrom the one or more surfaces defining the volume and the first opening.Further, or instead, the delivery of energy to the cutting tip can becontrolled to dissect tissue along the three-dimensional contouraccording to any one or more of the various different methods describedherein.

While certain implementations have been described, other implementationsare additionally or alternatively possible.

As yet another example, a transmitter for providing information about acup to a controller has been described as including an RFID tag, itshould be appreciated that other types of identification areadditionally, or alternatively, possible. For example, referring againto FIGS. 1-3, it should be understood that the transmitter 124 on thecup 102 can further or instead include a portion of an electricalcircuit. The portion of the electrical circuit can have one or moreelectrical properties indicative of the information related to the cup102. In use, the portion of the electrical circuit carried on the cup102 can be connectable to a receiver (e.g., a complementary portion of apin and socket connector or other similar physical connection) carriedon the cutting head 104 to complete an electrical circuit. Thecontroller 106 can determine the size of the cup 102 based on theelectrical properties of the completed electrical circuit. That is, acompleted electrical circuit including a smaller size of the cup 102 canhave different electrical characteristics than a completed electricalcircuit including a larger size of the cup 102. As compared to the useof RFID to provide size information of the cup 102, transmitting sizeinformation from the cup to the controller through electrical propertiesof a hardwired electrical circuit can be useful for verifying sizeinformation of the cup without the use of a separate communicationchannel and, further or instead, can also provide a useful indication ofa proper connection between the cup 102 and the cutting head 104.

In certain implementations, the portion of the electric circuit can havea predetermined impedance associated with size information of the cup102. As an example, a larger size of the cup 102 can have a largerimpedance than a smaller size of the cup 102. Continuing with thisexample, a detected impedance of the completed electrical circuit canprovide an indication of the size of the cup 102. In certain instances,if the detected impedance does not correspond to one or morepredetermined impedances, the controller 106 can provide an indicationto the physician to check the connection and/or to check the conditionof the cup 102. Further or instead, the controller 106 can lockactivation of the cutting head 104 unless and until an impedancematching the one or more predetermined impedances is detected,indicating that the cup 102 is appropriately connected to the cuttinghead 104.

Further or instead, the transmitter 124 can include one or more pinsassociated with size information of the cup. For example, with the cup102 connected to the cutting head 104, the position of the one or morepins of the transmitter 124 can identify the size of the cup 102. Thatis, detecting one or more pins associated with the cup 102 positioned inone or more corresponding receptacles of the cutting head 104 can beindicative of the size of the cup 102. As a more specific example,detecting a pin in a first position may be indicative of a first size ofthe cup 102, and detecting a pin in a second position may be indicativeof a second size of the cup 102.

As another example, while the transmitter 124 has been described asproviding information related to the size of the cup 102, it should beappreciated that the transmitter 124 can, further or instead, transmitother information, such as any manner and form of information useful forthe safe and effective use of the cup 102. For example, the transmitter124 may include a memory having stored thereon information related tothe use history of the cup 102. As a more specific example, the usehistory of the cup 102 may be incremented according to each detectedconnection of the cup 102 as part of the system 100—such as a connectionbetween the cup 102 and the cutting head 104, recognition of the cup 102by the controller 106, or other similar proxies for use of the cup 102.Further or instead, the use history of the cup 102 may be incrementedaccording to an input by the physician via the controller 106.

As still another example, while the transmitter 124 has been describedas being in electrical communication (e.g., via RF communication and/ordirect electrical connection) with the cutting head 104, it should bemore generally understood that communication between the transmitter 124and the cutting head 104 can include any manner and form ofcommunication useful for transmitting information from the transmitter124 (e.g., size and/or use history information) to the controller 106.Thus, for example, the transmitter 124 may be connectable in opticalcommunication with a corresponding receiver carried on the cutting head104 or other portion of the system 100. Continuing with this example,the transmitter 124 may include a QR code, a bar code, and/or othersimilar pattern associated with size of the cup 102. Further, orinstead, the transmitter 124 may be activatable (e.g., via aninterrogation signal including an optical signal) to transmit light of apredetermined wavelength associated with the size of the cup 102. Thatis, the size of the cup 102 may be determined based on a receivedwavelength (e.g., a detected color) associated with the cup 102.

As yet another example, while a suction channel has been described asextending through a cutting head, it should be appreciated that otherconfigurations are additionally, or alternatively, possible. Forexample, one or more suction channels can be defined or at leastpartially defined by a cup positioned over a breast of a patient.

As still another example, while the volume defined by the at least onesurface of the cup has been described as having certain shapes, othershapes are additionally or alternatively possible. For example,referring now to FIGS. 11A and 11B, a cup 102′ can have at least onesurface 112′ defining a volume 114′, and the at least one surface 112′of the cup 102′ can be frustoconical. Unless otherwise specified or madeclear from the context, it should be understood that the cup 102′ can beused interchangeably with the cup 102 (FIG. 1). Further, for the sake ofefficient description, elements with prime (′) element numbers in FIGS.10A and 10B should be understood to be similar to elements with unprimedelements numbers in FIGS. 1-4 and are not described separately, exceptto point out certain differences or emphasize certain aspects. Thus, forexample, the cup 102′ can be placed over a breast of a patient and,through the application of suction according to any one or more of themethods described herein, skin of the breast of the patient can be drawntoward the at least one surface 112′. As compared to other curved wallshapes, the frustoconical shape of the at least one surface 112′ can becost-effectively fabricated and, in some instances, can be fabricatedwith tighter dimensional tolerance. Further or instead, as compared tomore complex curved wall shapes, the frustoconical shape of the at leastone surface 112′ can facilitate determination of a three-dimensionalcontour based on the at least one surface 112′.

As yet another example, while a suction channel has been described asextending through a cutting head securable to a cup, it should beappreciated that other configurations are additionally or alternativelypossible for distributing suction along skin of the breast of thepatient. For example, referring to FIGS. 12A and 12B, a cup 102″ candefine at least partially define one or more suction channels 200 and,optionally, at least one surface 112″ a plurality of orifices 201 alongthe cup 102″ such that suction is applied at multiple locations alongthe breast of the patient. Unless otherwise specified or made clear fromthe context, it should be understood that the cup 102′ can be usedinterchangeably with the cup 102 (FIG. 1) and the cup 102′ (FIGS. 10Aand 10B). Further, for the sake of efficient description, elements withdouble prime (″) element numbers in FIGS. 12A and 12B should beunderstood to be similar to elements with unprimed elements numbers inFIGS. 1-4 and primed element numbers in FIGS. 11A and 11B and are notdescribed separately, except to point out certain differences oremphasis certain aspects. Thus, for example, the cup 102″ can be placedover a breast of a patient and, through the application of suctionaccording to any one or more of the methods described herein, skin ofthe breast of the patient can be drawn toward

The arrangement of the plurality of orifices 201 along the cup 102″ maybe in any one or more of various different patterns useful fordistributing vacuum suction along skin of the breast of the patient.That is, the pattern of the plurality of orifices 201 may beparticularly useful for drawing skin of the breast of the patient towardthe at least one surface 112″ to form a three-dimensional contour usefulfor carrying out any one or more of the various different methodsdescribed herein. Further, or instead, distribution of the vacuumsuction along the plurality of orifices 201 may be useful for holdingthe cup 102″ in place during a procedure.

As still another example, while movement of an extension arm has beendescribed as being achieved through the use of a linear actuator and anelectric rotary actuator, other types of actuation can additionally oralternatively be used to move the extension arm as required forpositioning a cutting tip along a three-dimensional contour. Forexample, referring now to FIG. 13, an actuator 109′ useable with acutting head (e.g., cutting head 104 in FIG. 2) can include a pivot arm136′, an extension arm 138′, a pivot joint 144′, a spring 302, pivotcables 304, and extension cables 306. Further, for the sake of efficientdescription, elements with primed numbers (′) in FIG. 13 should beunderstood to be similar to elements with unprimed element numbers inFIG. 2 and are not described separately, except to point outdifferences. Thus, for example, the extension arm 138′ can be coupled toa cutting tip such as the cutting tip 110 (FIG. 2).

A cutting tip attached to the actuator 109′ can be positioned throughactuation of the spring 302, the pivot cables 304, the extension cables306, or combinations thereof to move the pivot arm 136′ and theextension arm 138′. For example, the spring 302 can be positioned tobias movement of the extension arm 138′ to move a cutting tip away fromthe pivot joint 144′. Further, or instead, tension in the extensioncables 306 can be controlled to control movement of a cutting tip awayfrom the pivot joint 144′. That is, as tension in the extension cables306 is greater than the force of the spring 302, the extension cables306 can shorten the length of the extension arm 138′ to move a cuttingtip toward the pivot joint 144′. Continuing with this example, it shouldbe further appreciated that, as tension in the extension cables 306equals the force of the spring 302, the position of the extension arm138′ can be fixed. Similarly, as tension in the extension cables 306 isless than the force of the spring 302, the spring 302, the bias of thespring 302 can move the extension arm 138′ away from the pivot joint144′. Additionally, or alternatively, differences in tension between thepivot cables 304 can change an angle of the extension arm 138′ relativeto the pivot arm 136′.

The above systems, devices, methods, processes, and the like may berealized in hardware, software, or any combination of these suitable fora particular application. The hardware may include a general-purposecomputer and/or dedicated computing device. This includes realization inone or more microprocessors, microcontrollers, embeddedmicrocontrollers, programmable digital signal processors or otherprogrammable devices or processing circuitry, along with internal and/orexternal memory. This may also, or instead, include one or moreapplication specific integrated circuits, programmable gate arrays,programmable array logic components, or any other device or devices thatmay be configured to process electronic signals. It will further beappreciated that a realization of the processes or devices describedabove may include computer-executable code created using a structuredprogramming language such as C, an object oriented programming languagesuch as C++, or any other high-level or low-level programming language(including assembly languages, hardware description languages, anddatabase programming languages and technologies) that may be stored,compiled or interpreted to run on one of the above devices, as well asheterogeneous combinations of processors, processor architectures, orcombinations of different hardware and software. In another aspect, themethods may be embodied in systems that perform the steps thereof, andmay be distributed across devices in a number of ways. At the same time,processing may be distributed across devices such as the various systemsdescribed above, or all of the functionality may be integrated into adedicated, standalone device or other hardware. In another aspect, meansfor performing the steps associated with the processes described abovemay include any of the hardware and/or software described above. Allsuch permutations and combinations are intended to fall within the scopeof the present disclosure.

Embodiments disclosed herein may include computer program productscomprising computer-executable code or computer-usable code that, whenexecuting on one or more computing devices, performs any and/or all ofthe steps thereof. The code may be stored in a non-transitory fashion ina computer memory, which may be a memory from which the program executes(such as random access memory associated with a processor), or a storagedevice such as a disk drive, flash memory or any other optical,electromagnetic, magnetic, infrared or other device or combination ofdevices. In another aspect, any of the systems and methods describedabove may be embodied in any suitable transmission or propagation mediumcarrying computer-executable code and/or any inputs or outputs fromsame.

The method steps of the implementations described herein are intended toinclude any suitable method of causing such method steps to beperformed, consistent with the patentability of the following claims,unless a different meaning is expressly provided or otherwise clear fromthe context. So, for example performing the step of X includes anysuitable method for causing another party such as a remote user, aremote processing resource (e.g., a server or cloud computer) or amachine to perform the step of X. Similarly, performing steps X, Y and Zmay include any method of directing or controlling any combination ofsuch other individuals or resources to perform steps X, Y and Z toobtain the benefit of such steps. Thus, method steps of theimplementations described herein are intended to include any suitablemethod of causing one or more other parties or entities to perform thesteps, consistent with the patentability of the following claims, unlessa different meaning is expressly provided or otherwise clear from thecontext. Such parties or entities need not be under the direction orcontrol of any other party or entity, and need not be located within aparticular jurisdiction.

It will be appreciated that the methods and systems described above areset forth by way of example and not of limitation. Numerous variations,additions, omissions, and other modifications will be apparent to one ofordinary skill in the art. Absent an explicit indication to thecontrary, the disclosed steps may be modified, supplemented, omitted,and/or re-ordered without departing from the scope of this disclosure.In addition, the order or presentation of method steps in thedescription and drawings above is not intended to require this order ofperforming the recited steps unless a particular order is expresslyrequired or otherwise clear from the context. Thus, while particularembodiments have been shown and described, it will be apparent to thoseskilled in the art that various changes and modifications in form anddetails may be made therein without departing from the spirit and scopeof this disclosure and are intended to form a part of the invention asdefined by the following claims, which are to be interpreted in thebroadest sense allowable by law.

What is claimed is:
 1. A system for removal of tissue from a patient,the system comprising: a cup having at least one surface, the at leastone surface defining a volume and a first opening, and the volumepositionable about a breast of a patient with eat least one surface ofthe cup facing a skin surface of the breast and the first openingcircumscribing the breast of the patient; and a cutting head secured tothe cup, the cutting head including an actuator and a cutting tip, theactuator coupled to the cutting tip, and the actuator controllable tomove the cutting tip, within the volume, along a three-dimensionalcontour at one or more predetermined distances from the at least onesurface defining the volume and the first opening, wherein the cupincludes a transmitter including size information related to the cup,the cutting head includes a receiver configured to communicate with thetransmitter to receive a signal indicative of the size informationrelated to the cup.
 2. The system claim 1, wherein the transmitter isconfigured for wireless communication with the receiver.
 3. The systemof claim 1, wherein the actuator is controllable to move the cutting tipalong the three-dimensional contour parallel to the at least one surfaceof the cup.
 4. The system of claim 1, wherein at least one portion ofthe volume has a two-dimensional curvilinear profile in one or moreplanes perpendicular to the first opening.
 5. The system of claim 1,wherein the at least on surface of the cup further defines a secondopening, the volume extends from the first opening to the secondopening, and the cutting head extends through the second opening.
 6. Thesystem of claim 1, wherein the cutting head is releasably secured to thecup.
 7. The system of claim 1, wherein the actuator includes a pivot armand an extension arm coupled to the pivot arm, and the pivot arm and theextension arm are movable in coordination with one another to move thecutting tip along the three-dimensional contour.
 8. The system of claim1, wherein the cutting tip includes a resistance element, the cuttingtip defines a track, and the resistance element is movable back andforth along the track.
 9. The system of claim 8, wherein the cutting tipincludes one or more sensors adjacent to the resistance element.
 10. Thesystem of claim 9, wherein the one or more sensors include tissuesensors, with at least one of the tissue sensors disposed on each sideof the track along which the resistance element is movable.
 11. Thesystem of claim 9, wherein the one or more sensors include a pressuresensor arranged to detect contact pressure between the cutting tip andtissue.
 12. The system of claim 9, wherein the one or more sensorsinclude a capacitance sensor, a blood sensor, a temperature sensor, or acombination thereof.
 13. The system of claim 1, wherein at least one ofthe cutting head and the cup defines a suction lumen in fluidcommunication with the volume defined by the at least one surface of thecup.
 14. The system of claim 13, further comprising a suction source influid communication, via the suction lumen, with the volume defined bythe at least one surface of the cup, wherein, with the cup positionedabout the breast of the patient, the suction source is actuatable toform vacuum pressure in the volume to draw the skin surface of thebreast toward the at least one surface of the cup.
 15. The system ofclaim 1, wherein the at least one surface of the cup is rigid uponexposure to vacuum pressure.
 16. The system of claim 1, wherein thecutting tip defines a tip axis and the cutting tip is controllable tomove the tip axis tangent to the three-dimensional contour.